Purpose:
• The overall purpose of this study is to find out if the study medication is absorbed or eliminated from the body differently in participants with a moderate degree of liver impairment compared to participants with normal liver function. Another purpose is to assess the safety and tolerability of the study medication.
• This study is for research purposes only and is not intended to treat your liver disease
Method of Administration: Single oral dose of study medication
Investigator: Thomas Marbury, MD
To qualify:
• 18 to 75 years old
• Must have decreased liver function or disease such as fatty liver disease (NASH) or past history of Hepatitis C, alcohol related liver disease, or cirrhosis
• Volunteers may be taking medicines such as spironolactone (Aldactone®), furosemide (Lasix®), lactulose, or rifaximin (Xifaxan®)
• May also have ascites (fluid in your abdomen) or encephalopathy (brain condition that causes irritability or trouble sleeping)
Length/Duration:
• 1 eligibility screening visit
• 12 consecutive days and 11 nights in our research facility
• 1 follow-up visit
Location: 5055 South Orange Avenue, Orlando, FL 32809
Compensation Qualified participants will receive study medication, study related physical exams and laboratory tests
Qualified participants may be compensated up to $4,650 for time and travel related study expenses
Whom to Contact Recruitment Department: 407-240-7876
Orlando Clinical Research Center
5055 South Orange Avenue
Orlando, FL 32809
Recruiting Number: 407.240.7878